EP1675458B1 - Extrakorporale Organaufbewahrung - Google Patents
Extrakorporale Organaufbewahrung Download PDFInfo
- Publication number
- EP1675458B1 EP1675458B1 EP04762731A EP04762731A EP1675458B1 EP 1675458 B1 EP1675458 B1 EP 1675458B1 EP 04762731 A EP04762731 A EP 04762731A EP 04762731 A EP04762731 A EP 04762731A EP 1675458 B1 EP1675458 B1 EP 1675458B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- organ
- storage
- dialysate
- perfusion chamber
- extracorporeal
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Not-in-force
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Classifications
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0236—Mechanical aspects
- A01N1/0242—Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components
- A01N1/0247—Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
Definitions
- the invention relates to an arrangement for extracorporeal organ storage, which serves in a known manner to artificially maintain or regenerate the vital functions of organs.
- organs should also include extremities and tissue flaps and the like; Organ is used accordingly as a generic term.
- organ transport or in further biochemical or pharmacological examination of isolated organs.
- MR uses in a perfusion device such a liquid-filled closed organ perfusion chamber with cyclic pressure fluctuations for normothermic extracorporeal liver perfusion (transplantation of livers of non-cardiac donors in pig liver transplantation model - habilitation thesis 1999. Humboldt University Berlin).
- the proposed Organperfusionshunt is traversed by water, which is heated to about 37 ° C with an external heat exchanger. This circuit is required in addition to the perfusion circuit and the dialysate circuit.
- Corresponding excerpts from the habilitation thesis were published by MR Schön et. al. are also entitled "Liver Transplantation After Organ Preservation With Normothermic Extracorporeal Perfusion" in ANNALS OF SURGERY, Vol. 233, no. 1, pages 114-123 , released.
- EP 1 062 870 A2 an arrangement for extracorporeal organ storage is presented with at least one temperature-controlled organ perfusion chamber in which the organ is embedded in an impermeable protective cover.
- the protective cover is completely surrounded by a simultaneously used as a perfusate storage liquid, which is located in a box-like container.
- a dialysate cycle which is necessary for optimal storage of donor livers, is nowhere mentioned in this document.
- the invention has for its object to provide the simplest possible structure of an arrangement for extracorporeal organ storage. Especially in transplant surgery, the transport - and the maintenance of the functioning of the organs - is an essential task of a partially worldwide organ and transplantation logistics.
- the arrangement according to the invention for extracorporeal organ storage consists at least of an organ perfusion chamber with a controllable temperature device.
- Organperfusions an organ is embedded, which is covered by a protective cover.
- the protective cover is preferably designed as an impermeable plastic bag. The thus protected organ is completely suspended in a storage liquid.
- the invention is based on the idea to use the already existing dialysate as a storage liquid.
- the dialysate is an essential part of maintenance the vital functions of the organ and, as a result, also an essential component of the vitality-preserving circulation, which is composed of a dialysate circulation and a perfusate circulation, for the supply of the extracorporeal organ.
- the necessary dialysate circuit and the necessary aggregates are used to integrate the storage liquid as dialysate into the dialysate circuit and to use the organ perfusion chamber at the same time as storage for the dialysate.
- the Organperfusionshunt is hermetically sealed liquid and pressure tight. In addition to the medical necessity, a transportability by aircraft and helicopter is thus ensured in particular.
- the lining of the organ perfusion chamber, the protective cover and the dialysate are transparent.
- a controllable temperature device provides a normothermic or hypothermic ambient temperature to the extracorporeal organ.
- the temperature device is preferably designed as a heating mat, which lines the bottom of the Organperfusionshunt.
- the flow of dialysate ensures a uniform temperature of the isolated organ.
- the temperature device is integrated by heat or cold grinding in the wall of the Organperfusionshunt.
- probes record parameters and parameters, such as level, pressure, temperature, and process these signals for a display device or a digital process control.
- FIG. 1 shows a schematic representation of an arrangement for extracorporeal organ storage.
- the arrangement consists of a transparent Organperfusionshunt 1.
- the Organperfusionshunt is hermetically sealed with quick-closing liquid and pressure tight.
- As an organ 2 is in this embodiment a Liver stored at normothermic temperature.
- the protective cover 21 is an impermeable, transparent plastic bag.
- the sheathed member 2 is completely stored floating in a storage liquid 4.
- the storage liquid 4 is a dialysate and is a constituent of the vitality-maintaining circuit 5.
- a controllable temperature device 3 is integrated as a heating mat in the organ perfusion chamber 1.
- Several measuring probes 6 provide signals for a process control and a level indicator 61 illustrates the level of the storage liquid 4.
- Perpendicular to the Organperfusionshunt 1 is provided as a means for level indicator 61, a riser example. In Fig. 1 this riser is rotated by 90 ° in the sheet plane.
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- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Zoology (AREA)
- Dentistry (AREA)
- General Health & Medical Sciences (AREA)
- Wood Science & Technology (AREA)
- Health & Medical Sciences (AREA)
- Environmental Sciences (AREA)
- Physics & Mathematics (AREA)
- Thermal Sciences (AREA)
- Mechanical Engineering (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- External Artificial Organs (AREA)
Description
- Die Erfindung betrifft eine Anordnung zur extrakorporalen Organaufbewahrung, die in bekannter Weise dazu dient, die Vitalfunktionen von Organen künstlich aufrecht zu erhalten oder zu regenerieren. Im Folgenden soll der Begriff Organe auch Extremitäten und Gewebelappen und dergleichen umfassen; Organ wird dementsprechende als Oberbegriff verwendet.
- Ein wichtiges Einsatzgebiet ist insbesondere der Organtransport oder im weiteren biochemische oder pharmakologische Untersuchung an isolierten Organen.
- Einrichtungen für die Perfusion isolierter Organe sind bekannt.
- Schön, M. R. verwendet in einer Perfusionseinrichtung eine solche flüssigkeitsgefüllte geschlossene Organperfusionskammer mit zyklischen Druckschwankungen zur normothermen extrakorporalen Leberperfusion (Transplantation von Lebern nichtherzschlagender Spender im Schweineleber-Transplantationsmodell - Habilitationsschrift 1999. Humboldt Universität zu Berlin). Die vorgeschlagene Organperfusionskammer wird von Wasser durchströmt, das mit einem externen Wärmetauscher auf etwa 37 °C erwärmt wird. Dieser Kreislauf ist zusätzlich zum Perfusionskreislauf und zum Dialysatkreislauf erforderlich. Dementsprechende Auszüge aus der Habilitationsschrift wurden von M. R. Schön et. al. sind auch unter dem Titel "Liver Transplantation After Organ Preservation With Normothermic Extracorporeal Perfusion" in den ANNALS OF SURGERY, Vol. 233, No. 1, Seite 114-123, veröffentlicht.
- Auch in
DE 100 15 807 A1 undWO 94/28710 A1 - In
EP 1 062 870 A2 wird eine Anordnung zur extrakorporalen Organaufbewahrung mit mindestens einer temperaturgeregelten Organperfusionskammer vorgestellt, bei der das Organ in einer impermeablen Schutzhülle eingelagert ist. Die Schutzhülle ist vollständig von einer gleichzeitig als Perfusat genutzten Lagerflüssigkeit umgeben, die sich in einem kastenartigen Behälter befindet. Ein Dialysatkreislauf, der für eine optimale Lagerung von Spenderlebern notwendig ist, wird in dieser Schrift jedoch nirgendwo erwähnt. - Des Weiteren wird in
DE 43 42 728 A1 angeregt, Spenderlebern direkt in einer wässrigen, elektrolythaltigen Perfusionslösung zu lagern. Da die Leber jedoch in direktem Kontakt mit der Lösung steht, muss diese ein physiologisches Substrat für die Leber darstellen. Um dies zu erreichen ist es notwendig, der Perfusionslösung Sauerstoffträger, wie Perflurcarbon-Emulsionen, und Fettemulsionen beizugeben. Zusätzlich wird die Perfusionslösung mittels Durchleiten von gasförmigem Sauerstoff weiter mit Sauerstoff angereichert. Die Anreicherung der Lösung mit Sauerstoff und Fetten ist mit erheblichem Aufwand verbunden. - Der Erfindung liegt die Aufgabe zugrunde, einen möglichst einfachen Aufbau einer Anordnung zur extrakorporalen Organaufbewahrung zu schaffen. Insbesondere bei der Transplantationschirurgie ist der Transport - und die Aufrechterhaltung der Funktionsfähigkeit der Organe - eine wesentliche Aufgabe einer teilweise weltweit operierenden Organ- und Transplantationslogistik.
- Diese Aufgabe wird erfindungsgemäß durch die kennzeichnenden Merkmale des Hauptanspruches gelöst.
Weitere vorteilhafte Ausführungen ergeben sich aus den nachfolgenden Ansprüchen. - Die erfindungsgemäße Anordnung zur extrakorporalen Organaufbewahrung besteht mindestens aus einer Organperfusionskammer mit einer regelbaren Temperatureinrichtung.
In dieser Organperfusionskammer ist ein Organ eingelagert, welches von einer Schutzhülle ummantelt ist. Die Schutzhülle ist vorzugsweise als impermeabler Kunststoffbeutel ausgeführt. Das derart geschützte Organ ist vollständig schwebend in einer Lagerflüssigkeit eingelagert. - Der Erfindung liegt der Gedanke zugrunde, das ohnehin vorhandene Dialysat als Lagerflüssigkeit zu nutzen. Das Dialysat ist ein wesentlicher Bestandteil zur Aufrechterhaltung der Vitalfunktionen des Organs und infolge dessen auch wesentlicher Bestandteil des vitalerhaltenden Kreislaufes, der sich aus einem Dialysatkreislauf und einem Perfusatkreislauf zusammensetzt, zur Versorgung des extrakorporalen Organs. Erfindungsgemäß wird der notwendige Dialysatkreislauf und die dazu notwendigen Aggregate genutzt, die Lagerflüssigkeit als Dialysat in den Dialysatkreislauf einzubinden und die Organperfusionskammer gleichzeitig als Speicher für das Dialysat zu verwenden.
- Die Organperfusionskammer ist flüssigkeits- und druckdicht hermetisch geschlossen. Neben der medizinischen Notwendigkeit ist damit insbesondere eine Transportfähigkeit per Flugzeug und Hubschrauber gewährleistet.
- Die Bewandung der Organperfusionskammer, die Schutzhülle und das Dialysat sind transparent ausgeführt.
- Eine regelbare Temperatureinrichtung schafft für das extrakorporale Organ eine normotherme oder hypotherme Umgebungstemperatur. Die Temperatureinrichtung ist bevorzugt als Heizmatte ausgeführt, die den Boden der Organperfusionskammer auskleidet. Die Strömung des Dialysats sorgt für eine gleichmäßige Temperierung des isolierten Organs. In einer weiteren bevorzugten Ausführungsform ist die Temperatureinrichtung durch Wärme- bzw. Kälteschleifen in die Bewandung der Organperfusionskammer integriert.
- Mehrere Messsonden nehmen Kenngrößen und Parameter, beispielgebend Füllstand, Druck, Temperatur auf und machen diese Signale für eine Anzeigeeinrichtung oder einer digitalen Prozesssteuerung verarbeitbar.
- Im folgenden wird ein Ausführungsbeispiel der Erfindung anhand der beigefügten Zeichnung näher erläutert.
-
Figur 1 zeigt eine Schemadarstellung einer Anordnung zur extrakorporalen Organaufbewahrung. Die Anordnung besteht aus einer transparenten Organperfusionskammer 1. Die Organperfusionskammer ist mit Schnellverschlüssen flüssigkeits- und druckdicht hermetisch abgeschlossen. Als Organ 2 ist in dieser Ausführung eine Leber bei normothermer Temperatur eingelagert. Die Schutzhülle 21 ist ein impermeabler, transparenter Kunststoffbeutel.
Das ummantelte Organ 2 ist vollständig in einer Lagerflüssigkeit 4 schwebend eingelagert. Die Lagerflüssigkeit 4 ist ein Dialysat und ist ein Bestandteil des vitalerhaltenden Kreislaufes 5. Eine regelbare Temperatureinrichtung 3 ist als Heizmatte in der Organperfusionskammer 1 integriert. Mehrere Messsonden 6 liefern Signale für eine Prozesssteuerung und eine Füllstandsanzeige 61 verdeutlicht den Füllstand der Lagerflüssigkeit 4. Senkrecht auf der Organperfusionskammer 1 ist als Mittel zur Füllstandsanzeige 61 beispielgebend ein Steigrohr aufgesetzt. InFig. 1 ist dieses Steigrohr um 90° in die Blattebene gedreht. -
- 1
- Organperfusionskammer
- 2
- Organ
- 21
- impermeable Schutzhülle
- 3
- regelbare Temperatureinrichtung
- 4
- Lagerflüssigkeit/Dialysat
- 5
- Vitalerhaltender Kreislauf
- 51
- Dialysatkreislauf
- 52
- Perfusionskreislauf
- 6
- Messsonden
- 61
- Füllstandsanzeige
Claims (4)
- Anordnung zur extrakorporalen Organaufbewahrung mindestens bestehend aus einer Organperfusionskammer (1) mit einer regelbaren Temperatureinrichtung (3) und einem darin eingelagerten Organ (2), wobei das Organ (2) von einer impermeablen Schutzhülle (21) ummantelt und im weiteren vollständig von einer Lagerflüssigkeit (4) umgeben ist,
dadurch gekennzeichnet, dass die Lagerflüssigkeit (4) das Dialysat ist, welches Bestandteil eines vitalerhaltenden Kreislaufes (5), der sich aus einem Dialysatkreislauf (51) und einem Perfusatkreislauf (52) zusammensetzt, ist. - Anordnung nach Anspruch 1 dadurch gekennzeichnet, dass die Organperfusionskammer 1 flüssigkeits- und druckdicht abgeschlossen ist.
- Anordnung nach Anspruch 1 dadurch gekennzeichnet, dass die regelbare Temperatureinrichtung (3) als Heizmatte ausgeführt ist.
- Anordnung nach Anspruch 1 dadurch gekennzeichnet, dass die regelbare Temperatureinrichtung (3) in der Bewandung der Organperfusionskammer (1) integriert ist.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10340488A DE10340488B4 (de) | 2003-09-03 | 2003-09-03 | Extrakorporale Organaufbewahrung |
PCT/DE2004/001944 WO2005022994A1 (de) | 2003-09-03 | 2004-09-02 | Extrakorporale organaufbewahrung |
Publications (2)
Publication Number | Publication Date |
---|---|
EP1675458A1 EP1675458A1 (de) | 2006-07-05 |
EP1675458B1 true EP1675458B1 (de) | 2010-06-16 |
Family
ID=34258353
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP04762731A Not-in-force EP1675458B1 (de) | 2003-09-03 | 2004-09-02 | Extrakorporale Organaufbewahrung |
Country Status (5)
Country | Link |
---|---|
US (1) | US20070015131A1 (de) |
EP (1) | EP1675458B1 (de) |
AT (1) | ATE471076T1 (de) |
DE (2) | DE10340488B4 (de) |
WO (1) | WO2005022994A1 (de) |
Families Citing this family (20)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102007034130B4 (de) | 2007-07-21 | 2010-11-18 | Technische Universität Dresden | Vorrichtung zur Lagerung von druckempfindlichen Organen und Organteilen |
DE102007034132B4 (de) | 2007-07-21 | 2010-04-29 | Technische Universität Dresden | Perfusionsbeutel für explantierte Organe und Organteile |
ATE506851T1 (de) | 2007-07-21 | 2011-05-15 | Univ Dresden Tech | Vorrichtung und perfusionsbeutel zur lagerung von druckempfindlichen organen und organteilen |
CA2722615C (en) * | 2008-04-22 | 2018-01-16 | The Board Of Regents Of The University Of Texas System | Fluidics-based pulsatile perfusion organ preservation device |
EP2480069A1 (de) * | 2009-09-25 | 2012-08-01 | Board of Regents, The University of Texas System | Auf der strömungslehre basierende pulsierende perfusionserhaltungsvorrichtung und verfahren |
US9253976B2 (en) | 2011-03-15 | 2016-02-09 | Paragonix Technologies, Inc. | Methods and devices for preserving tissues |
US11178866B2 (en) | 2011-03-15 | 2021-11-23 | Paragonix Technologies, Inc. | System for hypothermic transport of samples |
US9867368B2 (en) | 2011-03-15 | 2018-01-16 | Paragonix Technologies, Inc. | System for hypothermic transport of samples |
US8828710B2 (en) | 2011-03-15 | 2014-09-09 | Paragonix Technologies, Inc. | System for hypothermic transport of samples |
WO2012125782A2 (en) | 2011-03-15 | 2012-09-20 | Paragonix Technologies, Inc. | Apparatus for oxygenation and perfusion of tissue for organ preservation |
US9426979B2 (en) | 2011-03-15 | 2016-08-30 | Paragonix Technologies, Inc. | Apparatus for oxygenation and perfusion of tissue for organ preservation |
US9560846B2 (en) | 2012-08-10 | 2017-02-07 | Paragonix Technologies, Inc. | System for hypothermic transport of biological samples |
US8785116B2 (en) | 2012-08-10 | 2014-07-22 | Paragonix Technologies, Inc. | Methods for evaluating the suitability of an organ for transplant |
CN102912376B (zh) * | 2012-10-10 | 2015-11-18 | 云南云铜锌业股份有限公司 | 一种锌电解铅阳极板及其制作方法 |
USD765874S1 (en) | 2014-10-10 | 2016-09-06 | Paragonix Technologies, Inc. | Transporter for a tissue transport system |
ES2675882B1 (es) * | 2017-01-12 | 2019-04-26 | Ebers Medical Tech S L | Equipo de perfusion de organos |
EP3634127A4 (de) | 2017-06-07 | 2021-03-17 | Paragonix Technologies Inc. | Vorrichtung zum transport und zur konservierung von gewebe |
US11632951B2 (en) | 2020-01-31 | 2023-04-25 | Paragonix Technologies, Inc. | Apparatus for tissue transport and preservation |
GB2591784A (en) * | 2020-02-06 | 2021-08-11 | Univ Strathclyde | Organ transport apparatus |
CN115123684A (zh) * | 2021-03-24 | 2022-09-30 | 四川省人民医院 | 一种用于肝肾移植的冷却保存装置 |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
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US3968346A (en) * | 1973-06-01 | 1976-07-06 | Cooksley Ralph D | Method and apparatus for electrically heating a fluid |
FR2667297B1 (fr) * | 1990-09-28 | 1994-05-27 | Electrolux Sarl | Conteneur medical climatise. |
DE9422008U1 (de) * | 1993-06-07 | 1997-08-28 | Mayer Berndt Priv Doz Dr Med | Vorrichtung zur Konservierung von Organen, Extremitäten und Gewebelappen |
DE4342728A1 (de) * | 1993-12-15 | 1995-06-22 | Thomae Gmbh Dr K | Verfahren, Apparate und Perfusionslösungen zur Konservierung explantierter Organe |
US6582953B2 (en) * | 1999-04-14 | 2003-06-24 | Breonics, Inc. | Organ chamber for exsanguinous metabolic support system |
DE19928485C1 (de) * | 1999-06-22 | 2000-10-19 | Jostra Medizintechnik Ag | Perfusionssystem für menschliche oder tierische Organe oder Körperteile |
DE10015807C2 (de) * | 2000-03-24 | 2002-09-19 | Mediport Biotech Gmbh | Verfahren und Vorrichtung zur Vitalerhaltung von Organen, Extremitäten und Gewebelappen durch Perfusion |
-
2003
- 2003-09-03 DE DE10340488A patent/DE10340488B4/de not_active Expired - Fee Related
-
2004
- 2004-09-02 AT AT04762731T patent/ATE471076T1/de not_active IP Right Cessation
- 2004-09-02 US US10/570,835 patent/US20070015131A1/en not_active Abandoned
- 2004-09-02 EP EP04762731A patent/EP1675458B1/de not_active Not-in-force
- 2004-09-02 WO PCT/DE2004/001944 patent/WO2005022994A1/de active Application Filing
- 2004-09-02 DE DE502004011287T patent/DE502004011287D1/de active Active
Non-Patent Citations (2)
Title |
---|
NEUHAUS P.: "Extrakorporale Leberperfusion: Entwicklung und Erprobung eines neuen Modells", HABILITATIONSCHRIFT ; MEDIZINISCHE HOCHSCULE HANNOVER, 1982, pages 29 * |
SCHÖN M.R.: "Transplantation von Lebern nicht-herzschlagender Spender im Schweineleber-Transplantationsmodell", HABILITATIONSSCHRIFT ZUR DER ERLANGUNG DER VENIA LEGENDI FUER DES FACH CHIRURGIE VORGRLEGT DER MEDIZINISCHEN FAKULTAET CHARITE DERHUMBOLDT-UNIVERSITAET ZU BERLIN, 1999, XP002314065 * |
Also Published As
Publication number | Publication date |
---|---|
DE10340488B4 (de) | 2007-05-10 |
WO2005022994A1 (de) | 2005-03-17 |
US20070015131A1 (en) | 2007-01-18 |
DE10340488A1 (de) | 2005-04-07 |
DE502004011287D1 (de) | 2010-07-29 |
ATE471076T1 (de) | 2010-07-15 |
EP1675458A1 (de) | 2006-07-05 |
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